MLX 300 WATT XENON LIGHT SOURCE Operation and Service
Contents
1. Allow a minimum of 2 inches 5 08 cm clearance at the rear and sides of the unit for cooling air flow Ensure that the unit is not near air exhaust or against other equipment WARNING The MLX light source monitors air intake temperature and will turn off if ambient temperature is gt 40 C OPERATION Insert a fiber optic cable in the proper port in the turret The active port is indicated by a on lt the front panel See Figure I Available ports are ACMI Olympus Storz and Wolf cable compatible All ports are identified appropriately 2 Press the Power Switch in the upper left corner of the front panel See Figure 2 3 When the Power Switch is pressed the Stand by Light Figure 2 will blink and there will be a 3 4 second delay before the Xenon Lamp illuminates while the system does a self diagnostic check 4 Press the Stand by Button L A i UXTEG Active Point LUNTEC MLX 300 WATT XENON LIGHT SOURCE OPERATION 5 The system will start up at the same light intensity as when last used Figure 3 For new systems the light intensity will start at the minimum 20 setting 6 To adjust the light intensity push the Membrane Switches Figure 3 to increase or to decrease the light output or intensity Range is 0 20 100 in 5 increments Holding the or button will change the intensity more quickly NOTE It is strongly recommended that the light be used at the minimum intensity for go2. 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds Floors should be wood concrete or ceramic tile If floors are synthetic the relative humidity should be at least 30 Mains power quality should be that of a typical commercial or hospital environment Note Tests Performed at both 240VAC 50Hz and 20VAC 60Hz Mains power quality should be that of a typical commercial or hospital environment Note Tests Performed at both 240VAC 50Hz and 20VAC 60Hz Mains power quality should be that of a typical commercial or hospital environment If the user of the MLX unit requires continued operation during power mains interruptions it is recommended that the MLX unit be powered from an uninterruptible power supply or battery Note Tests Performed at both 240VAC 50Hz and 20VAC 60Hz Power frequency magnetic fields should be that of a typical location in a typical commercial or hospital environment Note Tests Performed at both 50Hz and 60Hz CD GE 1e MLX 300 WATT XENON LIGHT SOURCE ELECTROMAGNETIC COMPATIBILITY EMC USER INFORMATION Table 204 Guidance and Manufacturer s Declaration Emissions Equipment and Systems that are NOT Life Supporting The MLX light source is intended for use in the electromagnetic environment specified below The customer or user of the MLX light source unit should ensure that it is used in such an environment Immunity
3. in all establishments including domestic and Conducted those directly connected to the public low voltage power supply network that CISPR 11 Emissions supplies buildings used for domestic purposes RF Emissions Conducted Emissions Tests Performed at both 240VAC 50Hz and 20VAC 60Hz Harmonics IEC 61000 3 2 Equipment intended for Professional Use Only Flicker l l IEC 61000 3 3 Equipment intended for Professional Use Only LUNTEC MLX 300 WATT XENON LIGHT SOURCE ELECTROMAGNETIC COMPATIBILITY EMC USER INFORMATION Table 202 Guidance and Manufacturer s Declaration Immunity All Equipment and Systems The MLX light source is intended for use in the electromagnetic environment specified below The customer or user of the MLX light source should assure that it is used in such an environment IEC 60601 Test Level Compliance Level Electromagnetic Environment Guidance Electrostatic Discharge ESD IEC 61000 4 2 Electrical Fast Transient burst IEC 61000 4 4 Surge IEC 61000 4 5 Voltage dips short interrup tions and voltage variations on power supply input lines IEC 61000 4 Power Frequency 50 60Hz Magnetic Field IEC 61000 4 8 6kV contact 8kV air 2kV on AC Mains kV Differential 2kV Common gt 95 Dip for 0 5 Cycle 60 Dip for 5 Cycles 30 Dip for 25 Cycles gt 95 Dip for 5 Seconds 6kV contact 8kV air 2kV on AC Mains kV Differential 2kV Common gt
4. 2 Remove the retaining screws from the top plate Figure 4 and retain screws 3 Slide the top plate towards the back of the unit until it stops 4 Lift the top cover up and off the unit 5 Unscrew the lamp module door and remove Figure 5 and retain screw 6 Grasp the module by the tabs and pull directly up Figure 6 i E x i Figure 5 Figure 6 Figure 7 To Replace Orient the lamp module P N 001320LX to face forward 2 Place the module into the light source 3 Seat module securely 4 Replace the lamp module door and secure it with the screw 5 Align top cover brackets into slots and slide forward 6 Slide the top plate forward until it engages the front panel 7 Replace the retaining screws in the rear panel 8 Replace the hospital grade power cord and turn on power to verify operation To Reset Lamp Age Meter Using the membrane switch turn the display to the lamp age system age screen 2 On the rear of the unit insert a pen pencil or other suitable pointed object into the slot marked RESET Figure 7 3 Push until a click is felt 4 Verify that the lamp age has been reset to 0 NOTE The System Age reading CANNOT be reset LUNTEC MLX 300 WATT XENON LIGHT SOURCE FUSE REPLACEMENT To replace the fuse e The fuse for the light source is located in the power entry module in the rear of the unit e Remove the hospital grade power cord from the back of the light source e Using a
5. CE REPLACEMENT PARTS AND ACCESSORIES To place an order contact your local Luxtec distributor or call Luxtec Customer Service at 800 325 8966 USA amp Canada only or 1 508 835 9700 to identify your local Luxtec representative Light Source OOMLX 300 Watt Xenon Light Source with Turret ACMI Wolf Storz and Olympus Accessories 001320LX Xenon Lamp Module 600987 Fuse 6 3 Amp Slow Blow 850469 Operating and Service Manual MLX light source Optional Accessories AX2100BIF UltraLite Pro headlight with 9ft 275cm premium bifurcated cable Mark Il module and gown clips AX2100BIFSL UltraLite Pro headlight with 9ft 275cm premium bifurcated cable Mark Il module and gown clips with short linkage 001337 MLX Floorstand MAINTENANCE AND CLEANING e Allow unit to cool for at least 15 minutes prior to cleaning Unplug the power cord before cleaning The light source exterior can be cleaned and disinfected using 70 isopropyl alcohol Allow 5 minutes for alcohol to evaporate before reconnecting to power Use a vacuum cleaner and a soft brush to remove visible dust accumulation from fan and vent holes whenever necessary and always when replacing the lamp CD GE 1e MLX 300 WATT XENON LIGHT SOURCE TROUBLESHOOTING Problem Cause Action No light output Light source not turned on Turn power on Bad no lamp Check lamp seating replace lamp module Attenuator closed Check position of knob on front panel Turret mispositio Rotate t
6. LUNTEC MLX 300 WATT XENON LIGHT SOURCE Operation and Service Manual ENGLISH 99 Hartwell Street West Boylston MA 01583 USA Tel 1 508 835 9700 US Toll Free 800 325 8966 Fax 1 508 835 9976 Website http www integra surgical com E mail custsvcluxtec integra surgical com MLX 300 WATT XENON LIGHT SOURCE LUNTEC TABLE OF CONTENTS PAGE AUAA KR UN 00 10 10 12 13 15 l6 7 7 DESCRIPTION Indication For Use Symbols General Warnings Precautions Overview Operation Xenon Lamp Module Replacement Fuse Replacement Optional Floor Stand Assembly Replacement Parts and Accessories Maintenance and Cleaning Troubleshooting Specifications Electromagnetic Compatibility EMC User Information Block Diagram Repair and Return Limited Warranty CD GE 1e7 MLX 300 WATT XENON LIGHT SOURCE INDICATION FOR USE The Luxtec MLX light source is designed to supply high intensity white light to a fiber optic cable for illumination of a surgical field during a surgical and or medical procedure MLX 300 WATT XENON LIGHT SOURCE CD Si10 SYMBOLS TABLE OF SYMBOLS Found on a medical grade light source other illumination related equipment fiber optic cables and corresponding packaging Attention Consult Accompanying Documents Fuse Type CF Equipment gt amp a a eo Caution High Voltage oe Equipotentiality Protective Eart
7. Test IEC 6060 Compliance Electromagnetic Environment Guidance Test Level Level Conducted RF 3Vrms from Portable and mobile RF communications equipment should IEC 61000 4 6 150 kHz to be separated from the MLX light source by no less than thg 80 MHz recommended separation distances calculated listed below D 3 5 VIWP Radiated RF IEC 61000 4 3 D 3 5 EVP 80 to 800 MHz D 7 EIWP 800 MHz to 2 5 GHz Where P is the maximum power rating in watts and D is the recommended separation distance in meters Field strengths from fixed transmitters as determined by an electromagnetic site survey should be less that the compliance levels VI and El Interference may occur in the vicinity of equipment containing a transmitter Table 206 Recommended Separation Distances Between Portable and Mobile RF Communications Equipment and the MLX Equipment and Systems that are NOT Life Supporting The MLX light source is intended for use in the electromagnetic environment in which radiated disturbances are controlled The customer or user of the MLX light source can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF Communications Equipment and the MLX light source as recommended below according to the maximum output power of the communications equipment Recommended Separation Distances for the MLX meters 150 kHz to 80 80 to 800MHz 800 MHz to 2 5 GHz MHz Max
8. e the light use if inspection reveals any damage such as case source has a turret with labeled selectable ports damage or loose connectors e Do not use the headlight at distances of less than e Follow the instructions of other manufacturer s 10 25cm equipment when used in conjunction with this product e To reduce the risk of fire and electric shock do not expose electrical equipment to moisture When cleaning do not immerse any electrical device in PRECAUTIONS liquid e Take precautions to verify that the fiber optic cable Do not use or store liquids on or above the light is appropriately suited for the light source Xenon Dai and other high illumination light sources require e SAFETY PRECAUTIONS MUST ALWAYS BE premium fiber optic cables in order to achieve EXERCISED WHEN USING ELECTRICAL optimal performance and prevent damage to the EQUIPMENT TO PREVENT OPERATOR PATIENT fibers thereby diminishing the quality of the light SHOCK FIRE HAZARD OR EQUIPMENT output or the useful life of fiber optic cable DAMAGE e Take precautions not to touch or disconnect the e Electric shock hazard If unit is not functioning cable end fitting from the turret until the Light properly DO NOT OPEN Please refer to the Source has been shut down for a period of time Repair aad Return Section of this Manual and allowed to cool The cable end fitting will remain hot immediately following shut down which e All electrical equi
9. h Type BF Equipment High Temperature On Off p Brightness Stand by Motor System Status Display ge Fan System CE Do Not Dispose Listed by ETL Push Listed by CSA us co isted by Hours Part Number Over Temperature LOT Batch Code Intensity Serial Number 2 Lamp Keep dry Authorized Representative in the European Community Manufacturer LUNTEC MLX 300 WATT XENON LIGHT SOURCE GENERAL WARNINGS e The user should carefully study the Operation e Explosion Hazard Do not use in the presence of and Service Manual before using the equipment flammable anesthetics liquids vapors gases or dusts in a clinical environment Instructions should be followed with special attention given to warnings e Keep cooling vent and fans free of obstructions controls and user specifications The Manual should be available to the appropriate personnel e FIRE HAZARD DO NOT DRAPE OR COVER THE LIGHT SOURCE WHILE IT IS OPERATING This Manual contains information about the proper procedures for preparing this product for its use e When light source is not in use turn off the power and care or put the unit in stand by mode e Before every procedure carefully inspect the light e Ensure that the fiber optic cable matches the port source to ensure it has been properly maintained type to prevent damaging the optical components and cleaned and that it is fully functional DO NOT of the light source For user convenienc
10. imum Output Power pn d 11667 P 1 1667VP d 2 33334 P 0 01 0 11667 0 11667 0 23333 0 1 0 36894 0 36894 0 73785 1667 1 1667 2 3333 10 3 6894 3 6894 7 3785 100 1 667 1 667 23 333 LUNTEC MLX 300 WATT XENON LIGHT SOURCE BLOCK DIAGRAM CD GE 1e MLX 300 WATT XENON LIGHT SOURCE REPAIR AND RETURN INFORMATION This device must be clean and decontaminated prior to return to Luxtec Luxtec reserves the right to return unrepaired any equipment that is contaminated with blood or other organic material Warranty Service and Repair To obtain service under warranty or return product for repair the customer should contact your local Luxtec representative or call Luxtec Customer Service at 1 800 325 8966 or 1 508 835 9700 LIMITED EXPRESS WARRANTY Luxtec warrants that the new MLX light source shall be free from defects in material and workmanship under normal use and service for a period of three 3 years from the date of shipment Luxtec s sole and exclusive liability under the warranty shall be at Luxtec s option either to repair any component which fails during the warranty period due to any defect in workmanship or material F O B factory if Customer promptly reports such defect to Luxtec in writing 2 If requested by Luxtec customer returns equipment to Luxtec with shipping charges and 3 Upon inspection Luxtec finds the equipment to be defective This warranty is contingent upo
11. n normal and proper use of the equipment It does not cover equipment that has been modified with non Luxtec parts without the written approval of Luxtec subjected to unusual physical or electrical stress or damaged during shipment This warranty is non transferable unless authorized in writing by Luxtec Luxtec reserves the right to make design changes on its products without liability to incorporate said change in Luxtec products previously designed or sold Upon receipt of the product it should be carefully inspected If any defect is discovered notification must be given immediately to the manufacturer or authorized distributor CD Gi e B INTEGRA Surgical www I ntegra Surgical com The Integra wave logo and Integra Surgical are trademarks of Integra LifeSciences Corporation Luxtec and UltraLite are registered trademark of Integra LifeSciences Corporation or its subsidiaries Copyright 2010 Integra LifeSciences Corporation All rights reserved THE INSTRUMENT PEOPLE USA Kk ge a
12. od visualization 7 The System Status Display can be pressed to show both lamp time and system operation time A second press of the switch will show the software version of the system monitor A third press returns to light output The system will automatically return to the light intensity reading after 15 seconds 8 The system can be placed in stand by mode no light emitted allowing the surgeon to unplug a headlight and move around the table or to change cables in a laparoscopic or endoscopic procedure CAUTION Cable end fitting can be HOT NOTE If unit is left in stand by mode for I5 minutes it will automatically shut off the lamp Fans will keep running To re activate push the Stand by Button 9 To shut the system off simply press the main Power Switch as in Step 2 LUXTEC Figure 3 XENON LAMP MODULE REPLACEMENT Note Please adhere to appropriate safety precautions when performing lamp replacement Only qualified personnel should service this device Protective facemask and or proper safety glasses should be worn when replacing the lamp module Before changing the lamp module turn power off and allow the light source to cool for at least fifteen 15 minutes Please read and comply with all Precautions and General Warnings listed in this manual LUNTEC MLX 300 WATT XENON LIGHT SOURCE XENON LAMP MODULE REPLACEMENT To remove Make sure the power is off and the hospital grade power cord is disconnected
13. ording to the Electromagnetic Compatibility EMC information provided in the accompanying documents WARNING Portable and Mobile RF Communications Equipment can affect Medical Electrical Equipment WARNING The equipment or system should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the equipment or system should be observed to verify normal operation in the configuration in which it will be used NOTE The EMC tables and other guidelines that are included in the Instruction Manual provide information to the customer or user that is essential in determining the suitability of the Equipment or System for the Electromagnetic Environment of use and in managing the Electromagnetic Environment of use to permit the Equipment or System to perform its intended use without disturbing other Equipment and Systems or non medical electrical equipment Table 201 Guidance and Manufacturer s Declaration Emissions All Equipment and Systems The MLX light source is intended for use in the electromagnetic environment specified below The customer or user of the MLX light source should assure that it is used in such an environment The MLX unit uses RF energy only for its internal function Therefore its RF Group emissions are very low and are not likely to cause any interference in nearby electronic equipment RF Emissions CISPR 11 Class B Radiated and The MLX unit is suitable for use
14. pment must be used with approved can cause burns hospital grade power cords and power plugs inserted properly into grounded AC power outlets e Take precautions to not place and rest a hot cable end fitting and or head light on a patient or allow the system to come in contact with un protected hands or tissue The entire system should be allowed to cool following use Failure to do so can cause burns and or tissue damage e The light source should never be used in ocular surgery or in a surgical procedure requiring direct illumination of the eye e Use care not to point any fiber optic cable directly at the eye while operating the light source e The light source produces high intensity light Thermal burns can result from improper use of the light source or from the light output of the fiber optic cable SD GE e MLX 300 WATT XENON LIGHT SOURCE OVERVIEW The MLX light source delivers 300 spare watts of cool white infrared IR filtered light The lamp is housed in a lamp module that can be easily serviced without special tools Set Up and Inspection Before Use The light source comes with the hospital grade power cord packaged separately Verify that both components are in good condition Before turning power on to the light source make sure the unit is plugged into any standard OOVAC to 240VAC 47 63Hz as appropriate outlet Grounding reliability is guaranteed only when connected to a hospital grade receptacle
15. small flat screwdriver pry open the retaining door Figure 8 and pry out the red plastic block from the power entry module Figure 9 e Check to see if the fuse is blown if blown replace with a fuse of the same rating Luxtec P N 600987 or T6 3AL250 e Replace the red block in the housing e Snap the retaining door into place e Plug cord back into light source and retest the unit Figure 9 CD GE 1e MLX 300 WATT XENON LIGHT SOURCE OPTIONAL FLOOR STAND ASSEMBLY There are four 4 parts to the floor stand assembly Figure 10 Phillips head screwdriver included for assembly Base with five 5 casters 2 locking 2 One column with light source base plate 3 Handle 4 MLX light source base Floor stand assembly instructions With the handle positioned so that the Luxtec logo is properly aligned slide the handle onto the column and center the handle about 5 inches 13cm below the light source base plate Tighten handle screw to hold in place 2 Insert assembled column into the base Seat firmly 3 Attach the light source base onto the base plate Figure 10 with the four 4 screws provided using the Phillips head screwdriver provided Figure 10 4 Secure the light source to base plate by aligning the feet to the holes on the surface of the plate Tighten the two screws on the bottom of the plate to the light source Figure 1 LUNTEC MLX 300 WATT XENON LIGHT SOUR
16. urret to desired adapter fitting Blown fuse Replace fuse as indicated in maintenance section Reduced light output Cable mismatched to turret Rotate turret to matching adapter fitting Attenuator mispositione Check position of knob on front panel Bad lamp Replace lamp module Plug in light source Close and secure top cover Lamp change Change lamp Module Part number will blink after 1000 hours 001320LX Fan failure Shut off unit to reset If it does not reset contact Luxtec for service Lamp overheat Shut off system to reset If it does not reset contact Luxtec for service Attenuator motor failure Shut off system to reset If it does not reset contact Luxtec for service CD GE 1e7 MLX 300 WATT XENON LIGHT SOURCE SPECIFICATIONS TAL 112 EEH 380mm L x 265mm W x 159mm H 12 5 bs 5 7 kg TO A40VAC 0 60Hz 10 450 Wals Maximum Leakage currant to chassis wih ground wire intact less than 100 micrmames Leakage current lo chassis wih groured wire inferrupted lass than 500 microames Type GF Glass 1 Type A Gavce CSA listed Confer t UL 60001 1 ard CSA Gee WO 601 1 ENG 1 1 2 20001 OG to 50C S2 F to 122 F 10 C to dO 50 F io 104 10 85 non condensing Hospital grade CD GE 1e MLX 300 WATT XENON LIGHT SOURCE ELECTROMAGNETIC COMPATIBILITY EMC USER INFORMATION WARNING Medical Electrical Equipment needs special precautions regarding EMC and needs to be installed and put into service acc
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